I work for a home health care company that is looking to import its products from China Mainland into Hong Kong and sell in the Hong Kong market. All of our products are fully licensed/registered in China Mainland (we have our business license, product license, and medical device registration in China) and we have both our business registration and place of business in Hong Kong.

We would like to register our products as Medical Devices, but this will take a minimum of 12 weeks and is also currently not mandatory as the registration is voluntary.

I have a few questions:

1. Initially, we would like to import our products without being registered as medical devices. From the online research that I have done, it appears it is not necessary to register our products in Hong Kong to be imported and sold in Hong Kong... is this true?

2. Can our products be imported into Hong Kong using their China product license? If not, what other documentation do I need?

3. We are registered as a medical device company in Hong Kong... is it then legal for us to sell non-medical device products or do they need to be registered as medical devices?

4. Our products are both medical devices and electronic devices... what type of procedure for declaration is there regarding importing the products into Hong Kong?

As of present there is no specific legislation in Hong Kong to regulate the importation or sale of medical devices into the territory except those containing pharmaceutical products or emitting ionizing radiation. However there are other regulations that should be observed such as the Electrical Products (Safety) Regulation, the Consumer Goods Safety Ordinance, and the Consumer Goods Safety Ordinance etc. Please check here into more details how the government classified medical devices and their requirements.